Oral drug delivery device with extendable arms

Abstract

To provide an oral drug delivery device having expanding arms to be activated in the small intestine to deliver a drug through a gastrointestinal wall.SOLUTION: A drug delivery device 100 is taken orally by a patient, and then activates within the gastrointestinal (GI) tract of the patient. Upon activation, resilient arms 215 within the drug delivery device 100 expand and engage the GI tract walls. A driver then drives a plunger 340 within the drug delivery device 100, pushing a drug through a channel 213 in the resilient arms 215 and through the GI tract walls of the patient. After a period of time, at least a portion of the drug delivery device 100 dissolves and the drug delivery device 100 passes through the GI tract.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to oral drug delivery devices. More particularly, the present disclosure relates to oral drug delivery devices having expandable arms that operate in the small intestine to deliver drugs through the gastrointestinal wall. [Background technology]

[0002] For patients being treated with drugs or other biologically active compounds, it is often most convenient to receive the compound orally. However, the properties of some compounds prevent them from maintaining their activity once ingested. For example, some compounds are denatured, digested, or inactivated when placed in the environment of the gastrointestinal (GI) system. In addition, some compounds have a low diffusion rate from the GI system to the bloodstream, which can prevent a sufficient dosage from being delivered to the patient. For compounds with these properties, patients often receive the compound via injection, which is painful and inconvenient. Therefore, it is desirable to develop an oral drug delivery device that can successfully deliver drugs that would otherwise be ineffective when taken orally. Summary of the Invention

[0003] The present disclosure provides a drug delivery device. The drug delivery device is orally ingested by a patient and then actuated within the patient's gastrointestinal (GI) tract. Upon actuation, arms within the drug delivery device extend and a penetrating tip penetrates the GI tract. A driver then drives a plunger within the drug delivery device, pushing the drug through the penetrating tip and the patient's GI tract wall. After a period of time, at least a portion of the drug delivery device dissolves and the drug delivery device passes through the GI tract.

[0004] In an exemplary embodiment, a drug delivery device is disclosed that includes: a capsule configured to disintegrate in a patient's gastrointestinal (GI) tract; a drug delivery mechanism within the capsule and configured to interface with a wall of the patient's GI tract, the drug delivery mechanism including a plurality of resilient arms, a plurality of GI wall interface ends, and a plurality of drug delivery channels, the plurality of GI wall interface ends being fluidly coupled to the plurality of drug delivery channels; a drug housing fluidly coupled to the drug delivery mechanism and configured to contain a volume of drug; and a drive mechanism coupled to the drug housing, the drive mechanism including a stopper, a trigger, and a driver, that actuates delivery of the drug via the drug delivery mechanism.

[0005] In another embodiment, a drug delivery device is disclosed comprising: a drug delivery mechanism located within the degradable capsule, the drug delivery mechanism including a degradable capsule, a fluid channel, and a plurality of drug delivery members; a drug housing fluidly coupled to the fluid channel configured to hold a volume of drug; and a drive mechanism coupled to the drug housing and at least partially located within the drug housing, the drive mechanism including a drug housing cap configured to fluidly seal the drug housing, a drive rod slidable within the drug housing, a drive stopper coupled to the drive rod configured to interface with the drug, a driver within the drug housing cap and coupled to the drive rod, and a dissolvable trigger configured to hold the drive rod in a first position, wherein the driver pushes the drive rod from the first position to a second position when the dissolvable trigger degrades, and wherein the drug is released through the drug delivery mechanism when the drive rod moves from the first position to the second position.

[0006] In yet another embodiment, an oral drug delivery device is disclosed that includes a housing capsule, a drug delivery mechanism within the housing capsule, the drug delivery mechanism including at least one drug delivery member configured to interface with a wall of the patient's gastrointestinal tract, a fluid channel within the at least one drug delivery member configured to allow the drug to flow through the drug delivery member, wherein the fluid resistance within the fluid channel is greater than the interstitial resistance due to the interface with the wall of the gastrointestinal tract, a drug housing coupled to the drug delivery mechanism, and a drive mechanism configured to drive the drug from the drug housing to the drug delivery mechanism.

[0007] In yet another embodiment, an oral drug delivery device is disclosed that includes a biodegradable capsule, a plurality of arms, and a liquid drug, the oral drug delivery device having a closed configuration in which the plurality of arms are disposed within the capsule, an open configuration in which the plurality of arms extend radially outward to contact a patient upon degradation of the capsule, a delivery configuration in which the liquid drug is injected into the patient through the plurality of arms, and a release configuration in which the plurality of arms are separated from the patient and pass through the patient. [Brief explanation of the drawings]

[0008] The above and other features and advantages of the present disclosure, as well as the manner in which they are achieved, will become more apparent, and the invention itself will be better understood, by referring to the following description of embodiments of the present invention in conjunction with the accompanying drawings.

[0009] [Figure 1] FIG. 1 is a perspective view of a drug delivery device according to the present disclosure. [Figure 2] FIG. 2 is an exploded perspective view of the drug delivery device of FIG. 1. [Figure 3] FIG. 2 is a right side view of the drug delivery device of FIG. 1. [Figure 4] FIG. 2 is a right cross-sectional view of the drug delivery device of FIG. 1. [Figure 5] FIG. 2 is a front view of the drug delivery device of FIG. 1. [Figure 6] FIG. 2 is a rear view of the drug delivery device of FIG. 1. [Figure 7] FIG. 2 is a perspective view of the drug delivery device of FIG. 1 in a closed position. [Figure 8] FIG. 8 is a perspective view of the drug delivery device of FIG. 7 in an open position. [Figure 9] FIG. 2 is a left side view of the drug delivery device of FIG. 1 in an open configuration within the GI tract of a patient, with the drive mechanism in a loaded position. [Figure 10] FIG. 10 is a side view of the drug delivery device of FIG. 9 with the drive mechanism in the delivery position. [Figure 11] FIG. 2 is a front view of the drug delivery device of FIG. 1 in an open configuration, delivering drug to the GI tract of a patient. [Figure 12] 2 is a partially exploded view of the drug delivery member of the drug delivery device of FIG. 1. [Figure 13] FIG. 2 is a partially exploded view of the drug delivery mechanism of the drug delivery device of FIG. 1. [Figure 14] FIG. 2 is a partial exploded view of the GI tract wall penetration system of the drug delivery device of FIG. 1. [Figure 15] FIG. 2 is a partial exploded view of the GI tract wall penetration system of the drug delivery device of FIG. 1. [Figure 16] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 17] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 18] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 19] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 20] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 21] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 22] FIG. 2 is a perspective view of the drug delivery device of FIG. 1. [Figure 23] 2 is an exemplary timeline for disassembly of the device of FIG. 1. [Figure 24] FIG. 2 is a perspective view of an assembly mechanism for use with the drug delivery device of FIG. 1. [Figure 25] 13A and 13B are cross-sectional and partial cross-sectional views of the assembly mechanism of FIG. 12. [Figure 26] 13A and 13B are cross-sectional and partial cross-sectional views of the assembly mechanism of FIG. 12. [Figure 27] FIG. 13 is a partial exploded view of some internal components of the assembly mechanism of FIG. 12. [Figure 28] 2 is a depiction of a method of assembling the drug delivery device of FIG. 1. [Figure 29] 2 is a depiction of a method of assembling the drug delivery device of FIG. 1. [Figure 30] 2 is a depiction of a method of assembling the drug delivery device of FIG. 1. [Figure 31] 2 is a depiction of a method of assembling the drug delivery device of FIG. 1. [Figure 32] 2 is a depiction of a method of assembling the drug delivery device of FIG. 1.

[0010] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate exemplary embodiments of the present invention, and such exemplifications should not be construed as limiting the scope of the present invention in any way. DETAILED DESCRIPTION OF THE INVENTION

[0011] 1-6, a drug delivery device 100 is shown. The drug delivery device 100 includes a capsule 110, a delivery mechanism 200, a drive mechanism 300, and a drug housing 400. The drug housing 400 may be referred to as a cartridge. When the drug delivery device 100 is fully assembled, the capsule 110 encloses the delivery mechanism 200, the drive mechanism 300, and the drug housing 400. As discussed in more detail herein, the drug delivery device 100 is configured to be orally ingested by a patient. Upon entering a portion of the patient's gastrointestinal (GI) tract, the capsule 110 disintegrates or otherwise breaks apart, thereby allowing the delivery mechanism 200 to interface with the inner walls of the GI tract and secure the drug delivery device 100 in place. Once the delivery mechanism 200 interfaces with the patient's GI tract, the drive mechanism 300 actuates delivery of the drug 500 from the drug housing 400 through the GI tract wall to the patient. As the drug 500 is delivered, the drug delivery device 100 passes through the GI tract.

[0012] 2, capsule 110 consists of two components: a first rear capsule portion 104 and a second front capsule portion 106. As will be discussed in more detail herein, first capsule portion 104 and second capsule portion 106 are joined together to form capsule 110.

[0013] The delivery mechanism 200 is configured to fit within the capsule 110 when the drug delivery device 100 is assembled. In the illustrated embodiment, the delivery mechanism 200 comprises a delivery base 230, a plurality of delivery members 210 extending from the delivery base 230, a membrane 220, and a central bore 250 extending through the delivery base 230. Each delivery member 210 comprises a resilient arm 215, a delivery channel 213, a joining end 217, and a piercing assembly 260. In the illustrated embodiment, three delivery members 210 extend from and are equally spaced around the delivery base 230, although in other embodiments any number of delivery members 210 and spacing arrangements may be used.

[0014] Delivery mechanism 200 is configured to allow fluid to flow from central bore 250 through delivery channel 213 to mating end 217. Delivery channel 213 is fluidly coupled to central bore 250 and extends along resilient arm 215. In the illustrated embodiment, delivery channel 213 is formed as an exposed groove in the outer surface of resilient arm 215. Referring to FIG. 12 , membrane 220 is bonded to the surface of resilient arm 215 to enclose and seal delivery channel 213. Membrane 220 may be bonded to the surface of resilient arm 215 by adhesive, welding (heat, UV, laser, ultrasonic, solvent, friction, injection, radio frequency, etc.), mechanical connection, or any other connecting means. The use of membrane 220 may simplify forming (e.g., molding, cutting) channel 213 in the outer surface of resilient arm 215. In other embodiments, delivery channel 213 may be a separate component, such as a tube, coupled to a portion of delivery mechanism 200. Additionally, the delivery channel 213 may be located entirely within the resilient arm 215 such that the interior of the delivery channel 213 is completely enclosed (eg, a bore through the resilient arm 215).

[0015] 14-15 , a mating end 217 is located near the end of each resilient arm 215 and is configured to interface with the interior of the patient's GI tract. The mating end 217 includes a socket 267 configured to receive a penetrating assembly 260. The penetrating assembly 260 includes a penetrating base 264 and a penetrating tip 266. As shown in FIG. 14 , in one embodiment, the penetrating tip 266 is separate from the penetrating base 264, and the penetrating base 264 includes a receiving bore 265 configured to couple the penetrating base 264 to the penetrating tip 266. In another embodiment, as shown in FIG. 15 , the penetrating base 264 and the penetrating tip 266 may be formed as a single piece. The socket 267 is configured to fluidly couple each delivery channel 213 to a corresponding penetrating tip 266 such that fluid can flow from the delivery channel 213 to the penetrating tip 266. At least one of the penetrating base 264 and the penetrating tip 266 may be biodegradable. In the exemplary embodiment, the mating end 217 interfaces with the inner wall of the GI tract and is generally parallel to the longitudinal axis A1, and the piercing tip 266 pierces or penetrates the GI tract wall and is generally perpendicular to the axis A1. After a predetermined time, the piercing base 264 and / or the piercing tip 266 disintegrate and exit the GI tract. In the illustrated embodiment, the piercing tip 266 has the shape of a hypodermic needle. In other embodiments, the piercing tip 266 may comprise a piercing tip with a fluid outlet located below the piercing tip (e.g., on a side of the piercing tip 266) to avoid blockages in the delivery of the drug 500. Additionally, each delivery member 210 may comprise any number of piercing tips 266, including an array of microneedles.

[0016] In another embodiment, connecting end 217 includes a liquid jet delivery mechanism for delivering fluid through the GI tract. In this embodiment, piercing assembly 260 (e.g., element 265) is formed as a nozzle or jet that delivers fluid from delivery channel 213 at high velocity to puncture and penetrate the GI tract without the use of a piercing tip 266 for drug delivery. In this embodiment, drive mechanism 300, including driver 360 as described herein, actuates delivery of drug 500 from drug housing 400 with a high force suitable for driving a liquid jet.

[0017] Referring again to Figures 1-6, in the illustrated embodiment, the delivery base 230 and delivery member 210 of the delivery mechanism 200 are constructed as a single, integral piece. In the illustrated embodiment, the delivery member 210 and delivery base 230 are resilient, having a stiff, spring-like characteristic adapted to allow the delivery member 210 to flex relative to the base 230, as described herein. In an exemplary embodiment, the delivery mechanism 200 is adapted to dissolve or biodegrade in the intestine following fluid delivery. In an exemplary embodiment, the delivery mechanism 200 is comprised of a polymer, such as a bioabsorbable / biodegradable polymer. Exemplary polymers include polyglycolic acid, polylactic acid, polycaprolactone, and copolymers and blends thereof, which may include polyethylene glycol. In other embodiments, the delivery mechanism 200 may be comprised of metal or other suitable materials. As shown in Figure 13, the delivery mechanism 200 may alternatively be constructed of multiple pieces connected through one or more linking members 270. In the illustrated embodiment of FIG. 13 , a connecting member 270 connects multiple delivery members 210 together at the delivery base 230. Furthermore, in the illustrated embodiment, the connecting member 270 is an I-shaped connector. In other embodiments, the connecting member 270 may be a fastener, screw, snap, pin, staple, or any other mechanical connecting means. The connecting member 270 may be made of a biodegradable material, including the bioabsorbable / biodegradable polymers described above, such that upon degradation of the connecting member 270, the delivery mechanism 200 breaks into separate pieces. Both the delivery members 210 and the connecting member 270 may be made of a biodegradable material, or only one of the delivery members 210 and the connecting member 270 may be made of a biodegradable material. In other embodiments, any component of the delivery mechanism 200 may be manufactured as separate pieces and connected together through the connecting member 270. Furthermore, the components of the delivery mechanism 200 may be connected to each other by adhesives, welding, or other connecting means.

[0018] Referring again to Figures 1-6, drug housing 400 is configured to fluidly couple with delivery mechanism 200 through housing coupling 450. Drug housing 400 is further configured to hold a volume of drug 500, generally in a liquid or other flowable form. In exemplary embodiments, drug 500 is a compound that typically has low efficacy when ingested by standard oral delivery and ingestion, such as a peptide or protein, e.g., insulin. In exemplary embodiments, drug 500 refers to, but is not limited to, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, combined GIP / GLP-1 agonists such as tirzepatide, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, and other suitable therapeutic agents. Drug 500 may also include vaccines or gene-based drugs. In other embodiments, drug 500 may be any biologically active compound administered to a patient. Drug housing 400 may be made of a polymer, metal, ceramic, crystalline solid, or any other material capable of retaining a volume of drug 500.

[0019] 16-21, in another embodiment of the drug delivery device 100, a seal assembly may be used between the drug housing 400 and the delivery mechanism 200 to retain the drug 500 in a sealed manner within the drug housing 400 until the drug 500 is ready to be introduced into the delivery mechanism 200. Referring initially to FIGS. 16-17, in one embodiment, the drug housing 400 may include a septum 420 configured to be pierced by a needle 415, similar to configurations commonly utilized by automatic injection systems known in the art. The needle 415 may be driven to pierce the septum 420 during a priming step of the drug delivery device 100, for example, when the drug delivery device 100 is assembled as shown in FIGS. 28-32. The needle 415 may also be driven through the septum 420 after the drug delivery device 100 has been ingested by a patient. For example, needle 415 may be actuated as a result of the degradation of capsule 110 or by including an additional degradable or force-providing component (not shown) that can actuate needle 415 upon degradation. In the illustrated embodiment, septum 420 is elastomeric and is coupled to drug housing 400 by overmolding. In other embodiments, septum 420 may be made of any material that is suitable for retaining drug 500 within drug housing 400 and that can be pierced by needle 415. Upon piercing septum 420 with needle 415, the interior of drug housing 400 is fluidly coupled to delivery mechanism 200 through connecting channel 450, allowing drug 500 to flow into delivery mechanism 200.

[0020] In the illustrated embodiment, the delivery mechanism 200 comprises a housing sleeve 233 coupled to the delivery base 230 and configured to couple the delivery mechanism 200 to the housing 400. The housing sleeve 233 may be a sleeve that fits completely around the housing 400 or may comprise several separate members. The housing sleeve 233 may also comprise a retention feature 231. The retention feature 231 may be a ridge, bump, groove, or other means for retaining the housing sleeve 233 on the housing 400. The housing 400 may also comprise a complementary feature that mates with the retention feature 231. Additionally, an adhesive or other form of bonding agent may be applied to the housing sleeve 233 and / or the housing 400 to help retain the housing sleeve 233 around the housing 400.

[0021] 18-19 , in another embodiment, the housing 400 may include a rupturable membrane 430 at the end of the connecting channel 450. The rupturable membrane 430 is configured to retain the drug 500 within the drug housing 400 until an increase in pressure ruptures the rupturable membrane 430 or otherwise allows passage of the drug 500 through the connecting channel 450. The increase in pressure may be caused by actuation of the plunger 340. In the illustrated embodiment, the housing 400 mates with the delivery base 230 at a housing interface 425. The housing interface 425 is configured to contact the delivery base 230 when the housing sleeve 233 engages the housing 400. The housing interface 425 may be coated with an adhesive or other bonding agent to aid in bonding the housing 400 to the delivery mechanism 200. The housing interface 425 may also include surface features such as ridges, bumps, grooves, or other retention features for mating with the delivery base 230. In such embodiments, the delivery base 230 may include complementary surface features.

[0022] 20-21, in yet another embodiment, the housing 400 may be molded closed to form an intentional weakness 440. The weakness 440 may be ruptured in a manner similar to the rupturable membrane 430, as described above, to allow the drug 500 to pass through the housing coupling 450. Embodiments including the rupturable membrane 430 and / or weakness 440 may not require the priming or activation step required by the needle 415 and septum 420 configuration shown in FIGS.

[0023] The drive mechanism 300 is configured to at least partially fit within the drug housing 400 and to actuate the flow of the drug 500 from the drug housing 400 to the delivery mechanism 200. The drive mechanism 300 includes a stopper 310, a plunger 340, a cap 330, a driver 360, and a trigger 350, and is disposed substantially coaxially with the longitudinal axis A1. The cap 330 seals the drug 500 within the drug housing 400 and at least partially encloses the driver 360. The plunger 340 includes a stopper end 342 adjacent the stopper 310 and a trigger end 344 adjacent the trigger 350, and is movable from a first loading position to a second delivery position substantially along the axis A1. The plunger 340 is coupled to the stopper 310 at its stopper end 342. In another embodiment, the plunger 340 is not coupled to the stopper 310. In embodiments, stopper 310 can be separated from drive mechanism 300 and inserted into drug housing 400 before drive mechanism 300 is coupled to drug housing 400. This separation allows drive mechanism 300 without stopper 310 to be assembled or manufactured separately from drug housing 400 and stopper 310 so that the drive mechanism can be coupled to drug housing 400 at a later time.

[0024] 9-10, the stopper 310 is configured to seal the drug 500 within the drug housing 400 and is slidable generally along axis A1. In a first loading position (see FIG. 9), the trigger 350 is disposed between the trigger end 344 and the cap 330, thereby preventing the trigger end 344 from passing through the cap 330 and further preventing movement of the plunger 340. In the first loading position, the driver 360 applies a force to the stopper end 342 generally toward the housing coupling 450. In the illustrated embodiment, the trigger 350 is made of a degradable material and configured to degrade over time. When the trigger 350 degrades and is removed from its position between the trigger end 344 and the cap 330, the force applied to the plunger 340 by the driver 360 moves the plunger 340 generally along axis A1 to a second delivery position (see FIG. 10). When moving from the first position to the second position, the plunger 340 and stopper 310 move generally toward the housing coupling 450, thereby reducing the available volume of the drug housing 400 and pushing the drug 500 from the drug housing 400 into the delivery mechanism 200.

[0025] In the illustrated embodiment, the driver 360 is a spring. In other embodiments, the driver 360 may be any member capable of delivering a force to move the plunger 340 from the first position to the second position, including a balloon, a piston, or a motor. In the illustrated embodiment, due to the presence of the cap 330, the stopper 310, plunger 340, and driver 360 all remain within the drug housing 400 after the drug delivery device 100 is actuated and the drug 500 is delivered. In this embodiment, the containment of most of the drive mechanism 300 within the drug housing 400 prevents additional, potentially damaging components from being released into the GI tract, instead retaining the components within the relatively smooth drug housing 400 that is ultimately passed by the patient.

[0026] 22 , trigger 350 includes an interior 352, an inner edge 353, a top surface 354, and at least one bevel 355. The bevel 355 may also be located at other points along the inner edge 353 or may even extend completely around the inner edge 353. Additionally, the top surface 354 may be angled downward toward the interior 352 over a portion or all of the trigger 350. The plunger 340 is configured to fit within the interior 352 of the trigger 350. The bevel 355, in conjunction with the generally horseshoe-shaped shape of the trigger 350, is configured to direct force from the driver 360 through the trigger end 344 of the plunger 340 and onto a smaller area of ​​the trigger 350. Thus, the trigger 350 is configured to break more easily than if the trigger 350 were a solid disk. Furthermore, because many biodegradable materials do not completely dissolve in a short amount of time, the shape and bevel 355 of trigger 350 prevents trigger 350 from catastrophically failing by snapping or breaking after a threshold level of degradation occurs. This configuration allows for relatively quick actuation of drive mechanism 300 once trigger 350 has degraded beyond the threshold amount.

[0027] 7-8, the drug delivery device 100 is movable from a first or closed state (see FIG. 7) to a second or open state (see FIG. 8). The delivery member 210 of the delivery mechanism 200 is made of a resilient material, such as a polymer, having flexible stiffness and spring-like properties. In the illustrated embodiment, when no force is acting on the delivery member 210, the natural state of the delivery member 210 is the open state. However, the delivery member 210 may be moved to the closed state, after which the resilience of the delivery member 210 allows it to bounce or expand back to the second state. In the closed state, the delivery member 210 is contained within the capsule 110 and lies generally parallel to the axis A1 (see FIG. 7). In the closed state, the delivery member 210 exerts a radially outward force on the interior of the capsule 110. Once the capsule 110 has degraded, dissolved, or otherwise disintegrated beyond a predetermined point, the delivery member 210 may break through the remaining capsule 110 and move radially outward from the axis A1 to enter an open state (see FIG. 8).

[0028] When the drug delivery device 100 is used to treat a patient, the patient orally accepts the drug delivery device 100, which travels through the patient's GI tract. In an exemplary embodiment, the capsule 110 disintegrates as the pH of the environment surrounding the drug delivery device 100 changes, for example, as the capsule 110 leaves the acidic stomach and enters the relatively alkaline small intestine. When the capsule 110 disintegrates by a threshold amount beyond the predetermined point, the drug delivery mechanism 200 breaks through the capsule 110, causing the delivery member 210 to extend outward. Within the patient's GI tract, as the delivery member 210 extends outward, the mating end 217 interfaces with the interior of the patient's GI tract, also referred to as a GI tract wall 700. The piercing tip 266 penetrates the GI tract wall 700, thereby securing the drug delivery device 100 to the wall 700 at the piercing point (see FIG. 9 ). The mating end 217 is configured to interface with a wall surface 710 as the piercing tip 266 penetrates the wall 700. In embodiments using liquid jet delivery, the spring force of delivery member 210 against wall 700 may be configured to provide sufficient anchoring force to deliver the drug. Additionally or alternatively, end 217 may include an abutment feature, such as a piercing tip or ridge, for gripping and anchoring device 100 to wall 700 during liquid jet delivery.

[0029] After the drug delivery device 100 penetrates the GI tract wall 700, the trigger 350 disintegrates beyond a threshold, allowing the driver 360 to drive the plunger 340 and stopper 310 into the drug housing 400, pushing the drug 500 through the delivery mechanism 200 (see FIG. 10 ) and through the penetrating tip 266 and into the wall 700 (see FIG. 11 ). After the drug 500 is delivered to the patient through the penetrating tip 266, the penetrating assembly 260 disintegrates. After the penetrating assembly 260 disintegrates beyond a threshold, the delivery mechanism 200 breaks or is released from the penetrating assembly 260 and passes through the GI tract. As mentioned above, other components of the delivery mechanism 200 may also break apart upon degradation of the coupling member 270. In some embodiments, components of the delivery mechanism 200 made of biodegradable / bioabsorbable polymers (described herein) are also adapted to degrade and dissolve following delivery of the drug.

[0030] 23, a depiction of the relative degradation times of different components of the drug delivery device 100 is shown according to one exemplary embodiment. In the illustrated embodiment, the first component to degrade is the capsule 110, exposing the internal components of the device 100 and allowing the device 100 to spring open and position itself within the GI tract. The next component to degrade is the trigger 350, thereby actuating the delivery mechanism 300 and delivering the drug 500 to the patient. The next component to degrade is the delivery member 210 and / or the coupling member 270, thereby allowing the drug delivery device 100 to pass through the remainder of the GI tract and be passed by the patient. Finally, the piercing assembly 260, or certain components within the piercing assembly 260, degrade. Both the capsule 110 and the trigger 350 degrade on the scale of approximately minutes or seconds. The delivery member 210 and / or the coupling member 270 degrade on the scale of approximately hours. The piercing assembly 260 or its components degrade on the order of hours or days. Components of the drug delivery device 100 may be designed to degrade on other suitable time scales in other embodiments.

[0031] In the exemplary embodiment, the delivery mechanism 200 includes a pressure regulator (not shown). When the piercing tips 266 penetrate the GI tract wall 700, a void pressure is created at the wall surface 710. In order for the drug 500 to move across the GI tract wall surface 710, the driver 360 must create a pressure within the drug 500 that is greater than the void pressure so that the drug 500 will flow through the wall 700. The pressure regulator sets a pressure threshold greater than the void pressure for each delivery member 210 such that the driver 360 must create a pressure within the drug 500 that is greater than the pressure threshold so that the drug 500 will flow through the delivery member 210. Thus, if one or more of the piercing tips 266 do not penetrate the wall 700, the disengaged piercing tips 266 that did not penetrate the wall 700 will still be subjected to the pressure threshold set by the pressure regulator, and a portion of the drug 500 will still be delivered through the engaged piercing tips 266 that penetrated the wall 700. In the absence of a pressure regulator, the majority of the drug 500 would escape through the piercing tip 266, which did not penetrate the wall 700, as this provides a path of less resistance.

[0032] In another embodiment, only one of the delivery members 210 may contain a delivery channel 213, and therefore only that one delivery member 210 may deliver the drug 500 to the patient. The other delivery member 210 may be configured to function as a "dummy" or structural delivery member 210 and may be present to help secure the drug delivery device 100 within the GI tract without functioning as a means for delivering the drug 500. The structural delivery member 210 may not include a piercing assembly 260, as the drug 500 does not flow through the delivery member 210 and then through the piercing assembly 260. The structural delivery member 210 may include joining features (not shown) on the joining end 217 to grip the GI tract wall 700. Such joining features may include ridges, protrusions, adhesive, or other gripping / attachment means. The structural delivery member 210 may also include microneedles, patches, solid drug deposits, or other drug delivery means that allow diffusion of a drug or other active agent through the wall 700 without penetration.

[0033] 24-27 , a device assembly mechanism 800 is provided to reduce the possibility of viscoelastic creep within the delivery mechanism 200. In an exemplary embodiment, a user or patient may receive the device assembly mechanism 800 and assemble the drug delivery device 100 immediately prior to oral ingestion of the drug delivery device 100. The device assembly mechanism 800 includes an assembly housing 820, an assembly actuator 810, an access window 825, a rotating member 850, a first drive rod 840, a second closure rod 845, and a device retrieval area 830. The assembly actuator 810 is configured to be pressed or otherwise actuated by a user to initiate assembly of a single drug delivery device 100 at a time. In the illustrated embodiment, the device assembly mechanism 800 is loaded with several drug delivery devices 100. The first capsule portion 104 and the internal components of the drug delivery device 100 (specifically, the delivery mechanism 200, the drive mechanism 300, the drug housing 400, and the drug 500) are held by a rotating member 850, and the second capsule portion 106 is held by an actuator 810. In the illustrated embodiment, the access window 825 may be removed to allow for additional loading of the device assembly mechanism 800. When the assembly actuator 810 is actuated, the first drive rod 840 drives the internal components of the drug delivery device 100 into the first capsule portion 104. The first drive rod 840 also brings the second capsule portion 106 into contact with the first capsule portion 104. The second capsule portion 106 and the first capsule portion 104 may be coupled by friction, welding, adhesive, mechanical fasteners, or other coupling means. Once the capsule 110 is completely formed around the internal components of the drug delivery device 100, the second closure rod 845 releases the drug delivery device 100 from the rotating member 850 and allows the drug delivery device to enter the device retrieval area 830. This process may be repeated before each drug delivery device 100 is orally ingested by the patient.

[0034] 28-32, an exemplary embodiment of the device assembly process is depicted. The drug housing 400 and drive mechanism 300 are combined and simplified in the drug drive unit 900. The delivery mechanism 200 is pushed into the first capsule portion 104, and the delivery member 210 enters a closed state in which it partially seals the drug drive unit 900. The drug drive unit 900 is pushed further into the delivery mechanism 200 such that the drug drive unit 900 and the delivery mechanism are fluidly coupled. Next, the second capsule portion 106 is pushed over the drug drive unit 900 and the delivery mechanism 200 and then sealed to the first capsule portion 104.

[0035] In another embodiment, the drug delivery device 100 may include a wireless communication device configured to transmit and / or receive signals to and from a wireless receiver (not shown). The wireless communication device may be configured to measure or sense biological information within the patient after the drug delivery device 100 is ingested. For example, the wireless receiver may transmit a signal when the delivery mechanism 200 expands or when a portion of the drug delivery device 100 degrades. Additionally, the wireless communication device may measure / sense other biological information within the GI tract, such as chemical concentrations, pH, temperature, or other biological information. The wireless receiver may be used by the patient receiving treatment or by another user, such as a doctor or caregiver. The wireless communication device and the wireless receiver may communicate through RFID, magnetic acoustic, near-field communication, ultrasound, Bluetooth technology, or other wireless communication means.

[0036] While this invention has been described as having an exemplary design, the invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

Claims

1. 1. A drug delivery device comprising: a capsule configured to disintegrate in the gastrointestinal (GI) tract of a patient; a drug delivery mechanism within the capsule, the drug delivery mechanism including a base and a plurality of arms extending from the base at a first axial end of the drug delivery mechanism and spaced apart around the base; Equipped with The drug delivery mechanism comprises: a closing configuration, the plurality of arms being disposed within the capsule and extending toward a second axial end opposite the first axial end; an open configuration in which the arms extend radially outward from the base at an axial angle toward the second axial end to contact a wall of the patient's GI tract after disintegration of the capsule; and a delivery arrangement for delivering a drug from at least one of the plurality of arms into the GI tract wall of the patient; having Drug delivery devices.

2. In the closed configuration, the arms are parallel to a longitudinal axis of the drug delivery mechanism. The drug delivery device of claim 1 .

3. the drug delivery mechanism further comprises a release configuration in which the plurality of arms are separated from the GI tract wall and passed through the patient. The drug delivery device of claim 1 .

4. each of the plurality of arms having a wall-engaging end, the wall-engaging end including a piercing tip configured to pierce a wall of the GI tract of the patient in the open configuration and the delivery configuration; The drug delivery device of claim 3 .

5. the piercing tip is configured to disintegrate within the patient's GI tract to separate the plurality of arms from the GI tract wall in the release configuration. The drug delivery device of claim 4.

6. The piercing tip is a dissolvable needle structure. The drug delivery device of claim 4.

7. a housing coupled to the drug delivery mechanism and containing the drug; the base of the drug delivery mechanism is disposed at an axial end of the housing; The drug delivery device of claim 1 .

8. In the closed configuration, the arms are disposed adjacent to the housing. The drug delivery device of claim 7.

9. a drive mechanism coupled to the housing; the drive mechanism includes a trigger and a plunger movable within the housing in response to disassembly of the trigger; the drug delivery mechanism transitions to the delivery configuration after the trigger at least partially disassembles and the plunger moves within the housing; The drug delivery device of claim 7.

10. the base, the housing, and the drive mechanism are arranged along a longitudinal axis; 10. The drug delivery device of claim 9.

11. each of the plurality of arms including a drug delivery channel formed therein and in fluid communication with the housing; The drug delivery device of claim 7.

12. the plurality of arms being circumferentially spaced about the base of the drug delivery mechanism; A drug delivery device according to any one of claims 1 to 11.

13. the plurality of arms are coupled to the base via a plurality of fusible coupling members; the dissolvable coupling member is configured to degrade in the patient's GI tract. A drug delivery device according to any one of claims 1 to 11.

14. 1. A drug delivery device comprising: a capsule configured to disintegrate in the gastrointestinal (GI) tract of a patient; a drug delivery mechanism disposed within the capsule and including at least one drug delivery member; a housing coupled to the drug delivery mechanism and configured to hold a volume of drug; a drive mechanism coupled to the housing and disposed at least partially within the housing; Equipped with The drive mechanism a housing cap coupled to the housing; a plunger movable within the housing; a driver coupled to the plunger; Equipped with the driver pushing the plunger from a first position to a second position after the capsule disintegrates in the GI tract; When the plunger moves from the first position to the second position, the drug is delivered from the housing through the drug delivery mechanism; the housing cap prevents the drive mechanism from disengaging from the housing and entering the GI tract after delivery of the drug. Drug delivery devices.

15. the at least one drug delivery member extends from a base of the drug delivery mechanism; the base, the housing, and the drive mechanism are arranged along a longitudinal axis; 15. The drug delivery device of claim 14.

16. the drug delivery mechanism is configured to transition from a closed position to an open position after the capsule disintegrates; the at least one drug delivery member is disposed adjacent the housing in the closed position and expands radially outward toward the open position to interface with a wall of the GI tract of the patient.

15. The drug delivery device of claim 14.

17. the at least one drug delivery member includes a mating end and a channel in fluid communication with the housing and the mating end, the mating end including a piercing tip configured to pierce the GI tract wall; 15. The drug delivery device of claim 14.

18. the drive mechanism further comprising a dissolvable trigger that retains the plunger in the first position.

15. The drug delivery device of claim 14.

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